Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Endpoint summary

Description of key information

The sensitization potential of the test chemical was determined by performing patch tests on humans

No positive reactions were reported by the patients tested. The test chemical can be considered as a non- sensitizer in humans.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: Patch test

Principles of method if other than guideline:

Patch test was performed on humans to evaluate the dermal sensitization potential of the test chemical

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

The available data is sufficient for the classification of the substance thus non LLNA mehtod is accepatble. Also data is from relaible sources which confirm the classfication of the substance.

Species:

human

Sex:

male/female

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

2% in petrolatum

Day(s)/duration:

2-3 days

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

2% pet.

Day(s)/duration:

3 days

Adequacy of challenge:

not specified

No. of animals per dose:

9 patients

Details on study design:

Details on study design
OTHER: The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.
The reactions of the patients were graded as?+. + and ++ categories

Challenge controls:

no data

Positive control substance(s):

not specified

Key result

Reading:

1st reading

Group:

test chemical

Dose level:

2% in pet.

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

no dermal reactions observed

Remarks on result:

no indication of skin sensitisation

Table 1:  Patch test results

 

Chemical	No of patients tested	?+	+	++
6358 -69 -6 (2% in pet.)	9	0	0	0

Interpretation of results:

other: not sensitizing

Conclusions:

No positive reactions were reported by the patients tested. The test chemical can be considered as a non- sensitizer in humans.

Executive summary:

The sensitization potential of the test chemical was determined by performing patch tests on humans.

2% test chemical in petrolatum was applied in Finn Chambers to the skin of 9 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories 9 patients were tested with the dye.

No positive reactions were reported by the patients tested. The test chemical can be considered as a non- sensitizer in humans.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Various studies have been reviewed to evaluate the dermal sensitization potential of the test chemical in living organisms. These include in vivo experimental studies on humans, guinea pigs for the various test chemicals. The results are summarized below:

The sensitization potential of the test chemical was determined by performing patch tests on humans.

2% test chemical in petrolatum was applied in Finn Chambers to the skin of 9 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories 9 patients were tested with the dye.

No positive reactions were reported by the patients tested. The test chemical can be considered as a non- sensitizer in humans.

This is supported by a study for test chemical carried out in guinea pigs to determine its sensitization efficacy.

Since the guinea pigs did not elicit any sensitizing effect, the test chemical considered to be not sensitizing to the guinea pigs.

These results are supported by a sensitization study carried out on guinea pigs to assess the dermal sensitization potential of the test chemical.

During the induction phase, Guinea pigs were subcutaneously given 10 doses of 1ml of 0.05-0.1% solution in isotonic saline (duration of exposure, number of animals not specified).A challenge test was also conducted after 14 days of induction.

No dermal reactions were observed in guinea pigs during the induction and challenge exposure. Hence, the test chemical can be considered to be not sensitizing to guinea pig skin.

The above results are supported by a Maximization test performed on guinea pigs to assess the  dermal sensitization potential of the test chemical. The study was performed according to OECD 406 Guidelines. 15 female (10 test group, 5 control group) Ibm: GOHI guinea pigs were used for the study.

The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No skin sensitization reaction was observed. Hence the test chemical was considered to be not skin sensitizing in guinea pig.

Based on the results from the available studies for the test chemicals, the test chemical can be considered to lack the potential to cause any dermal sensitization to skin. Hence, by applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results from the available studies for the test chemicals, the test chemical can be considered to lack the potential to cause any dermal sensitization to skin. Hence, by applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin.